Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Drug: GnRH analog and recombinant human FSH; Drug: Clomifene Citrate

• Registration Number: NCT01389713
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent a demanding challenge for clinicians. It has classically been claimed that using higher dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation and increase the chances of success. However, scientific evidence supporting this view is scanty and costs are inevitably much higher. In this study, the investigators hypothesized that similar chances of pregnancy may be achieved with a mild stimulation using exclusively Clomiphene citrate (CC).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-07
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Last Update Submitted: 2011-07-11
• Last Update Posted: 2011-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 289

Inclusion Criteria

• age 18-42 years
• infertility status
• Day 3 serum FSH > 12 IU/ml in at least two occasions or previous poor response (≤3 oocytes retrieved) to hyper-stimulation

Exclusion Criteria

• contraindications to infertility treatments or pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High doses	GnRH analog and recombinant human FSH	Administration of high doses of gonadotrophins to stimulate ovarian follicular growth
Clomid	Clomifene Citrate	Administration of Clomiphene Citrate to obtain ovarian follicular growth

Primary Outcome Measures

Name	Time	Method
live birth rate	end of the study (28 months)	general "Live birth rate" will be recorded at the end of the study when all participants have performed their In vitro Fertilization (IVF) treatment.; Live birth rate per single patients will be recorded 4 weeks after embryo transfer when a intrauterine gestational sac is expected to be seen in case of pregnancy.

Secondary Outcome Measures

Name	Time	Method
ratio pregnancies/costs	end of the study (28 months)	at the end of the study the number of obtained pregnancies will be divided by the total costs of treatments in two groups. A cost in euros will be therefore estimated for every single pregnancy in both groups.

Trial Locations

Locations (1)

Fondazione Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy